SciaticaNCT04918238
Effect of Muscle Energy Techniques on Functional Abilities in Patients With Discogenic Unilateral Sciatica
A study testing Conventional program and Muscle energy technique in people with Sciatica and Low Back Pain, run by Horus University at 1 site in Egypt.
Trial summary
The purpose of the study to investigate the effect of muscle energy techniques on functional abilities of patients with chronic discogenic unilateral sciatica and to explain it from a physiological and functional point of view Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatica, Low Back Pain
- What is being tested?
- Conventional program and Muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
- Both males and females, aged from 25 to 40 years old.
- Be able to understand and follow the instructions during testing and treatment procedures
Who cannot join
- Fracture of pelvis, spine or lower extremities.
- Hospitalization for severe trauma.
- Peripheral neuropathy of diabetes or any other autoimmune disease.
- Systematic autoimmune disease such as rheumatoid arthritis, systematic lupus
- People with red flags such as cancer or severe osteoporosis.
- Symptoms provoked while doing active hip joint extension and abduction.
Show all 11Show fewer
- Previous surgery to the lumbar spine, abdomen, pelvis, or hip.
- Any contraindication for exercise therapy (e.g. uncontrolled hypertension, previous myocardial infarction, cardiovascular disease, peripheral vascular disease, respiratory disorders).
- Any pain originated because of SI pathology.
- Menstruation during testing days.
- Individuals incapable of understanding and answering the Questionnaire.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Horus University
Damietta, 34518
About this study
The purpose of the study to investigate the effect of muscle energy techniques on functional abilities of patients with chronic discogenic unilateral sciatica and to explain it from a physiological and functional point of view
Read the detailed description
Disability and emotional distress among patients with lumbar spondylosis has a negative impact on well-being. Anxiety and depression are common emotional problems among patients with LBP.
The experience of pain interferes with different aspects of the patient's life, negatively affecting their daily activities, physical and mental health, family and social relationships, and their interactions in the workplace.
This problem also affects the health care system and what is known as economic well-being, the strong burden associated with Chronic Pain not only deriving from healthcare costs but also from the loss of productivity and from compensatory payments to patients as a result of the disability that pain produces.
Movement research has vast implications for muscle energy techniques for individuals with chronic low back pain and sciatica, the thoracolumbar normal range of motion plays an essential role in transferring the body weight and performing daily activities. Poor spinal range of motion and tightness of paraspinal muscles have previously been noted in individuals with chronic low back pain and sciatica.
Most of the previous studies focused on dealing with chronic low back pain and sciatica through using different medications and physical therapy modalities for the symptoms such as TENS. Since muscle energy techniques can decrease the tension of the muscles of the lumbar spine and gives a real chance to improve the flexibility of those muscles which might inhibit the severity of sciatica with low costs so it's recommended to study its effect on the functional abilities of the patients so that it can be the main part of physical therapy rehabilitation protocol.
- Conditions
- Sciatica, Low Back Pain
- Being tested
- Conventional program, Muscle energy technique
- Medical subject headings
- Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional programOther
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
Muscle energy techniqueOther
The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject. The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment Arm | Active comparator | All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle. Receives: Other: Conventional program |
| muscle energy technique arm | Experimental | Group A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program Receives: Other: Conventional program; Other: Muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Change from baseline Pain and at 2 months
Measured: "through study completion, an average of 2 months"
Oswestry disability index scale
Change from baseline disability and at 2 months
Measured: "through study completion, an average of 2 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Feb 2021
- Primary completion15 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basem Muhammad Khalefa, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918238
- Sponsor's protocol ID
- Basem_MSc
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Energy Techniques on Functional Abilities in Patients With Discogenic Unilateral Sciatica
- ClinicalTrials.gov ID
- NCT04918238
- Acronym / sponsor ID
- Basem_MSc
- Conditions
- Sciatica, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to investigate the effect of muscle energy techniques on functional abilities of patients with chronic discogenic unilateral sciatica and to explain it from a physiological and functional point of view
Detailed description
Disability and emotional distress among patients with lumbar spondylosis has a negative impact on well-being. Anxiety and depression are common emotional problems among patients with LBP.
The experience of pain interferes with different aspects of the patient's life, negatively affecting their daily activities, physical and mental health, family and social relationships, and their interactions in the workplace.
This problem also affects the health care system and what is known as economic well-being, the strong burden associated with Chronic Pain not only deriving from healthcare costs but also from the loss of productivity and from compensatory payments to patients as a result of the disability that pain produces.
Movement research has vast implications for muscle energy techniques for individuals with chronic low back pain and sciatica, the thoracolumbar normal range of motion plays an essential role in transferring the body weight and performing daily activities. Poor spinal range of motion and tightness of paraspinal muscles have previously been noted in individuals with chronic low back pain and sciatica.
Most of the previous studies focused on dealing with chronic low back pain and sciatica through using different medications and physical therapy modalities for the symptoms such as TENS. Since muscle energy techniques can decrease the tension of the muscles of the lumbar spine and gives a real chance to improve the flexibility of those muscles which might inhibit the severity of sciatica with low costs so it's recommended to study its effect on the functional abilities of the patients so that it can be the main part of physical therapy rehabilitation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment Arm | Active comparator | Other: Conventional programAll the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle. |
| muscle energy technique arm | Experimental | Other: Conventional program, Other: Muscle energy techniqueGroup A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
Key exclusion criteria (11 listed)
- Fracture of pelvis, spine or lower extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional programAll the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle. | Other | conventional treatment Arm, muscle energy technique arm |
| Muscle energy techniqueThe patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject. The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated. | Other | muscle energy technique arm |
Primary outcome
Visual analogue scale (VAS)
Time frame: "through study completion, an average of 2 months"
Change from baseline Pain and at 2 months
Oswestry disability index scale
Time frame: "through study completion, an average of 2 months"
Change from baseline disability and at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Sciatica
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional program and Muscle energy technique in people with Sciatica and Low Back Pain, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: "through study completion, an average of 2 months"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.